Dosing and uses of Advil PM (diphenhydramine-ibuprofen)
Adult dosage forms and strengths
diphenhydramine/ibuprofen
caplet
- 25mg/200mg
- 38mg/200mg
Pain
Indicated for occasional sleeplessness when associated with mild-to-moderate pain; includes mild sedative ingredient (diphenhydramine)
2 caplets PO at bedtime; not to exceed 2 caplets/24 hr
Pediatric dosage forms and strengths
diphenhydramine/ibuprofen
caplet
- 25mg/200mg
- 38mg/200mg
Pain
Indicated for occasional sleeplessness when associated with mild-to-moderate pain; includes mild sedative ingredient (diphenhydramine)
<12 years: Safety and efficacy not established
>12 years: 2 caplets PO at bedtime; not to exceed 2 caplets/24 hr
Geriatric dosage forms and strengths
Diphenhydramine considered a high risk medication for the elderly as it may increase the risk of falls
Not recommended as sleep aid for elderly individuals
Advil PM (diphenhydramine-ibuprofen) adverse (side) effects
Frequency not defined
Diphenhydramine
- Sedation
- Confusion
- Anticholinergic effects
- May decrease cognitive function in geriatric patients
- Xerostomia
- Pharyngeal and nasal mucosa dryness
- Thick sputum
Ibuprofen
- Nausea
- Vomiting
- Epigastric pain
- Rash
- Edema
- Tinnitus
Warnings
Contraindications
Hypersensitivity to NSAIDs or aspirin
Active GI bleeding disorder
Breastfeeding
Cautions
Asthma (bronchial), cardiac disease, CHF, hepatic/renal impairment, hypertension
Avoid driving or operating machinery
Coadministration with alcohol will increase sedation
Diphenhydramine: Caution in narrow angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, or bladder neck obstruction
Cardiovascular risk
- NSAIDs may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), & stroke, which can be fatal
- Risk may increase with duration of use
- Patients with risk factors for or existing cardiovascular disease may be at greater risk
- NSAIDs are contraindicated for perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (increased risk of MI & stroke)
Gastrointestinal risk
- NSAIDs increase risk of serious GI adverse events including bleeding, ulceration, & perforation of the stomach or intestines, which can be fatal
- GI adverse events may occur at any time during use & without warning symptoms
- Elderly patients are at greater risk for serious GI events
Pregnancy and lactation
Pregnancy category
Diphenhydramine: B
Ibuprofen: C; D from 30 weeks of gestation onward (may cause premature closure of the ductus arteriosus)
The Quebec Pregnancy Registry identified 4705 women who had spontaneous abortions by 20 weeks' gestation; each case was matched to 10 control subjects (n=47,050) who had not had spontaneous abortions; exposure to nonaspirin NSAIDs during pregnancy was documented in approximately 7.5% of cases of spontaneous abortions and in approximately 2.6% of controls. (CMAJ, September 6, 2011; DOI:10.1503/cmaj.110454)
Lactation
Diphenhydramine: Enters breast milk; may decrease breast milk production; contraindicated with breast feeding
Ibuprofen: Excreted into breast milk; not recommended (AAP Committee states "compatible with nursing")
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Advil PM (diphenhydramine-ibuprofen)
Mechanism of action
Diphenhydramine: Histamine H1-receptor antagonist with low-to-moderate antihistamine properties and moderate-to-high anticholinergic/antiemetic properties
Ibuprofen: Inhibits synthesis of prostaglandins in body tissues by inhibiting cyclooxygenase; at least 2 isoenzymes, cyclooxygenase-1 (COX-1) & -2 (COX-2)
